ENTERPRISE SPONSOR: CRO
SanaClis, one of Our Road to CPhI Milano sponsors discuss how they are preparing to face the future of healthcare.
The Mission of the Company
SanaClis is proud to offer a comprehensive range of services for clinical trials and ensures an efficient drug development process for pharma and biotech companies. For the sponsor wanting to accelerate drug development and reduce costs by working with one CRO that offers the full range of needed services, SanaClis is a key partner option. A number of CROs have offices across Europe but actually outsource many aspects to third-party vendors, leading to unnecessary delays and costs to the sponsor. Of course, a sponsor can hire a global CRO that will outsource these services, but that would have a negative impact on their budget, especially in proof-of-concept studies. Increased numbers of sponsors complicate communication, which can cause delays.
While SanaClis retains core operations in the European Union and Eurasia (e.g., Ukraine, Russia, Georgia), they have initiated operations and capabilities in North America after receiving a significant surge in demand for their CRO services and supply chain management. The company is implementing the very latest technologies and capabilities across all departments and facilities to ensure that the expanded operations maintain the level of excellence of SanaClis’ European facilities.
The amount of newly registered clinical trials in Central and Eastern Europe (CEE) indicate that the region is fast becoming a global hub for both US and Western European companies conducting global clinical studies in which patient recruitment is fundamental and challenging. By expanding their reach into emerging countries, the benefits are considerable. There is less competition for clinical trials at the selected sites, highly motivated investigators, and data of consistently high quality. The CEE region provides highly motivated patients, well-qualified investigators, and efficient trials, while maintaining lower costs, all of which are attracting sponsors to the region. The resulting cost savings can ultimately be rerouted to secure the appropriate number and criteria of patients for the study. The CEE population is greater than either the United States or the five largest Western European markets combined. This in turn makes patient recruitment in emerging markets more fruitful, for several reasons, including fewer regulations and the availability of treatment-naïve populations.
The lack of access to innovative medications in the CEE region is also a crucial factor for the successful recruitment in clinical studies, as is a centralized healthcare system, which consequently permits the possibility of utilizing fewer sites but with a higher patient-per-site ratio, as we see in developed markets. Patient recruitment is consistently one of the top three challenges sponsors face when conducting clinical trials in the United States and Western Europe, particularly in certain therapeutic areas, such as oncology, where it is challenging to find naïve patient populations. As a result, many large pharma companies and biotechs are looking to significantly expand their phase II–III clinical trials more broadly into emerging countries, yet still maintain a solid foothold in traditional countries. Since SanaClis has the capabilities and vital expertise in both markets, they are well positioned to assist sponsors in the execution of their clinical strategy.